EP4248895A1

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Publication number: EP4248895A1
Application number: EP23163976.6A
Authority: EP
Inventors: Kevin Mark OKARSKI; Keshava Datta; Abubakarr Bah; Thanh Nguyen
Original assignee: Biosense Webster Israel Ltd
Current assignee: Biosense Webster Israel Ltd
Priority date: 2022-03-25
Filing date: 2023-03-24
Publication date: 2023-09-27
Also published as: JP2023143877A; US20230301707A1

Abstract

The disclosed technology includes a medical probe comprising a tubular shaft extending along a longitudinal axis of the medical probe. The medical probe further comprises an expandable basket assembly coupled to the distal end of the tubular shaft. The basket assembly comprises a plurality of spines and a plurality of electrodes. The electrode comprises an electrode body that defines a lumen therethrough such that the respective spine extends through the lumen. The basket assembly comprises an electrically insulative jacket disposed between each respective spine and each respective electrode. Each electrode body and electrically insulative jacket comprises a substantially circular cross-sectional shape.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. § 119 to prior filedU.S. Provisional Application No. 63/323,832, filed on March 25, 2022, the entire contents of which is incorporated herein by reference in its entirety as if fully set forth herein.

FIELD

The present invention relates generally to medical devices, and in particular catheters with cylindrical electrodes, and further relates to, but not exclusively, catheters suitable for use to induce irreversible electroporation (IRE) of cardiac tissues.

BACKGROUND

Cardiac arrhythmias, such as atrial fibrillation (AF), occur when regions of cardiac tissue abnormally conduct electric signals to adjacent tissue. This disrupts the normal cardiac cycle and causes asynchronous rhythm. Certain procedures exist for treating arrhythmia, including surgically disrupting the origin of the signals causing the arrhythmia and disrupting the conducting pathway for such signals. By selectively ablating cardiac tissue by application of energy via a catheter, it is sometimes possible to cease or modify the propagation of unwanted electrical signals from one portion of the heart to another.

Many current ablation approaches in the art utilize radiofrequency (RF) electrical energy to heat tissue. RF ablation can have certain risks related to thermal heating which can lead to tissue charring, burning, steam pop, phrenic nerve palsy, pulmonary vein stenosis, and esophageal fistula.

Cryoablation is an alternative approach to RF ablation that generally reduces thermal risks associated with RF ablation. Maneuvering cryoablation devices and selectively applying cryoablation, however, is generally more challenging compared to RF ablation; therefore cryoablation is not viable in certain anatomical geometries which may be reached by electrical ablation devices.

Some ablation approaches use irreversible electroporation (IRE) to ablate cardiac tissue using nonthermal ablation methods. IRE delivers short pulses of high voltage to tissues and generates an unrecoverable permeabilization of cell membranes. Delivery of IRE energy to tissues using multi-electrode catheters was previously proposed in the patent literature. Examples of systems and devices configured for IRE ablation are disclosed in U.S. Patent Pub. No. 2021/0169550A1,2021/0169567A1, 2021/0169568A1,2021/0161592A1,2021/0196372A1,2021/0177503A1, and2021/0186604A1, each of which are incorporated herein by reference and attached in the appendix to priority application63/323,832.
Regions of cardiac tissue can be mapped by a catheter to identify the abnormal electrical signals. The same or different catheter can be used to perform ablation. Some example catheters include a number of spines with electrodes positioned thereon. The electrodes are generally attached to the spines and secured in place by soldering, welding, or using an adhesive. Due to the small size of the spines and the electrodes, however, soldering, welding, or adhering the electrodes to the spines can be a difficult task, increasing the manufacturing time and cost and the chances that the electrode fails due to an improper bond or misalignment. What is needed, therefore, are devices and methods of forming an improved basket assembly that can help to reduce the time required for manufacturing the basket assembly, alternative catheter geometries, and alternative electrode shapes and sizes in general.

SUMMARY

Various embodiments of a medical probe and related methods are described and illustrated. The medical probe may include a tubular shaft including a proximal end and a distal end. The tubular shaft can extend along a longitudinal axis of the medical probe. The medical probe can include an expandable basket assembly proximate the distal end of the tubular shaft. The basket assembly can include a plurality of spines extending along the longitudinal axis and converging at a central spine intersection. The central spine intersection can include one or more cutouts that allows for the spines to bow radially outward from the longitudinal axis when the expandable basket assembly is transitioned from a collapsed form to an expanded form. Each spine of the plurality of spines can include a plurality of electrodes. The respective electrode can include an electrode body that defines a lumen therethrough such that the respective spine can extend through the electrode body lumen. The basket assembly can include an electrically insulative jacket disposed between each respective spine and each respective electrode. Each electrode body and electrically insulative jacket can have a substantially circular cross-sectional shape.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic pictorial illustration of a medical system including a medical probe whose distal end includes a basket assembly with electrodes, in accordance with an embodiment of the present invention;
FIG. 2A is a schematic pictorial illustration showing a perspective view of a medical probe in an expanded form, in accordance with an embodiment of the present invention;
FIG. 2B is a schematic pictorial illustration showing a side view of a medical probe in a collapsed form, in accordance with embodiments of the present invention;
FIG. 2C is a schematic pictorial illustration showing an exploded side view of a medical probe, in accordance with an embodiment of the present invention;
FIG. 2D is an exploded view of components for an example contact force sensor shown inFIG. 2C, in accordance with an embodiment of the present invention;
FIG. 3A is a perspective view of a medical probe in an expanded form, in accordance with an embodiment of the present invention;
FIG. 3B illustrates a cross-sectional view of a respective spine, insulative jacket, and electrode ofFIG. 3A, in accordance with an embodiment of the present invention;
FIGs. 4A-4C are schematic pictorial illustrations showing a perspective view of various example electrodes, in accordance with embodiments of the present invention;
FIG. 5A provides schematic pictorial illustrations showing various insulative jackets of a given medical device, in accordance with embodiments of the present invention;
FIGs. 5B-5D are schematic pictorial illustrations showing a frame extrusion of a given medical device, in accordance with embodiments of the present invention;
FIGs. 5E-5G are schematic pictorial illustration of example frame extrusion fixtures positioned on a spine, in accordance with embodiments of the present invention;
FIGs. 6A and 6B are schematic pictorial illustrations showing cross-sectional views of a given wire of a medical probe, in accordance with an embodiment of the present invention;
FIGs. 7A through 7E are schematic pictorial illustrations of central spine intersections, in accordance with an embodiment of the present invention;
FIGs. 8A and 8B are schematic pictorial illustrations showing a profile outline of a basket assembly of a given medical device, in accordance with embodiments of the present invention;
FIG. 9 is a schematic pictorial illustration showing a side view of a plurality of spines forming a basket assembly, in accordance with an embodiment of the present invention;
FIGs. 10A and 10B are schematic pictorial illustrations of a method of forming a basket assembly, in accordance with an embodiment of the present invention;
FIG. 10C illustrates an embodiment where the proximal end of each spine is provided with a hole and reference notches to ensure correct alignment and retention of the spine to the irrigation tube, in accordance with an embodiment of the present invention;
FIG. 10D illustrates an embodiment that relies on a balloon to expand the spine assembly, in accordance with an embodiment of the present invention;
FIG. 10E illustrates a spine assembly formed by cutting a cylindrical tube stock with a laser, in accordance with an embodiment of the present invention;
FIG. 10F illustrates a spine assembly after shape setting of the spines inFig. 10E into a spheroidal basket like shape, in accordance with an embodiment of the present invention; and
FIG. 11 is a flowchart illustrating another method of assembling a basket assembly, in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION

The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.
As used herein, the terms "about" or "approximately" for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, "about" or "approximately" may refer to the range of values ±20% of the recited value, e.g. "about 90%" may refer to the range of values from 71% to 110%.
As used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject invention in a human patient represents a preferred embodiment. In addition, vasculature of a "patient," "host," "user," and "subject" can be vasculature of a human or any animal. It should be appreciated that an animal can be a variety of any applicable type, including , but not limited thereto, mammal, veterinarian animal, livestock animal or pet type animal, etc. As an example, the animal can be a laboratory animal specifically selected to have certain characteristics similar to a human (e.g., rat, dog, pig, monkey, or the like). It should be appreciated that the subject can be any applicable human patient, for example. As well, the term "proximal" indicates a location closer to the operator or physician whereas "distal" indicates a location further away to the operator or physician.
As discussed herein, "operator" can include a doctor, surgeon, technician, scientist, or any other individual or delivery instrumentation associated with delivery of a multi-electrode catheter for the treatment of drug refractory atrial fibrillation to a subject.
As discussed herein, the term "ablate" or "ablation", as it relates to the devices and corresponding systems of this disclosure, refers to components and structural features configured to reduce or prevent the generation of erratic cardiac signals in the cells by utilizing non-thermal energy, such as irreversible electroporation (IRE), referred throughout this disclosure interchangeably as pulsed electric field (PEF) and pulsed field ablation (PFA). Ablating or ablation as it relates to the devices and corresponding systems of this disclosure is used throughout this disclosure in reference to non-thermal ablation of cardiac tissue for certain conditions including, but not limited to, arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablate" or "ablation" also includes known methods, devices, and systems to achieve various forms of bodily tissue ablation as understood by a person skilled in the relevant art.
As discussed herein, the terms "bipolar" and "unipolar" when used to refer to ablation schemes describe ablation schemes which differ with respect to electrical current path and electric field distribution. "Bipolar" refers to ablation scheme utilizing a current path between two electrodes that are both positioned at a treatment site; current density and electric flux density is typically approximately equal at each of the two electrodes. "Unipolar" refers to ablation scheme utilizing a current path between two electrodes where one electrode including a high current density and high electric flux density is positioned at a treatment site, and a second electrode including comparatively lower current density and lower electric flux density is positioned remotely from the treatment site.
As discussed herein, the terms "biphasic pulse" and "monophasic pulse" refer to respective electrical signals. "Biphasic pulse" refers to an electrical signal including a positive-voltage phase pulse (referred to herein as "positive phase") and a negative-voltage phase pulse (referred to herein as "negative phase"). "Monophasic pulse" refers to an electrical signal including only a positive or only a negative phase. Preferably, a system providing the biphasic pulse is configured to prevent application of a direct current voltage (DC) to a patient. For instance, the average voltage of the biphasic pulse can be zero volts with respect to ground or other common reference voltage. Additionally, or alternatively, the system can include a capacitor or other protective component. Where voltage amplitude of the biphasic and/or monophasic pulse is described herein, it is understood that the expressed voltage amplitude is an absolute value of the approximate peak amplitude of each of the positive-voltage phase and/or the negative-voltage phase. Each phase of the biphasic and monophasic pulse preferably has a square shape including an essentially constant voltage amplitude during a majority of the phase duration. Phases of the biphasic pulse are separated in time by an interphase delay. The interphase delay duration is preferably less than or approximately equal to the duration of a phase of the biphasic pulse. The interphase delay duration is more preferably about 25% of the duration of the phase of the biphasic pulse.
As discussed herein, the terms "tubular" and "tube" are to be construed broadly and are not limited to a structure that is a right cylinder or strictly circumferential in cross-section or of a uniform cross-section throughout its length. For example, the tubular structures are generally illustrated as a substantially right cylindrical structure. However, the tubular structures may have a tapered or curved outer surface without departing from the scope of the present disclosure.
The term "temperature rating", as used herein, is defined as the maximum continuous temperature that a component can withstand during its lifetime without causing thermal damage, such as melting or thermal degradation (e.g., charring and crumbling) of the component.
The present disclosure is related to systems, methods or uses and devices which utilize end effectors including electrodes affixed to spines. Example systems, methods, and devices of the present disclosure may be particularly suited for IRE ablation of cardiac tissue to treat cardiac arrhythmias. Ablative energies are typically provided to cardiac tissue by a tip portion of a catheter which can deliver ablative energy alongside the tissue to be ablated. Some example catheters include three-dimensional structures at the tip portion and are configured to administer ablative energy from various electrodes positioned on the three-dimensional structures. Ablative procedures incorporating such example catheters can be visualized using fluoroscopy.
Ablation of cardiac tissue using application of a thermal technique, such as radio frequency (RF) energy and cryoablation, to correct a malfunctioning heart is a well-known procedure. Typically, to successfully ablate using a thermal technique, cardiac electropotentials need to be measured at various locations of the myocardium. In addition, temperature measurements during ablation provide data enabling the efficacy of the ablation. Typically, for an ablation procedure using a thermal technique, the electropotentials and the temperatures are measured before, during, and after the actual ablation.
RF approaches can have risks that can lead to tissue charring, burning, steam pop, phrenic nerve palsy, pulmonary vein stenosis, and esophageal fistula. Cryoablation is an alternative approach to RF ablation that can reduce some thermal risks associated with RF ablation. However maneuvering cryoablation devices and selectively applying cryoablation is generally more challenging compared to RF ablation; therefore, cryoablation is not viable in certain anatomical geometries which may be reached by electrical ablation devices.
IRE as discussed in this disclosure is a non-thermal cell death technology that can be used for ablation of atrial arrhythmias. To ablate using IRE/PEF, biphasic voltage pulses are applied to disrupt cellular structures of myocardium. The biphasic pulses are non-sinusoidal and can be tuned to target cells based on electrophysiology of the cells. In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to produce heat at the treatment area, indiscriminately heating all cells in the treatment area. IRE therefore has the capability to spare adjacent heat sensitive structures or tissues which would be of benefit in the reduction of possible complications known with ablation or isolation modalities. Additionally, or alternatively, monophasic pulses can be utilized.
Electroporation can be induced by applying a pulsed electric field across biological cells to cause reversable (temporary) or irreversible (permanent) creation of pores in the cell membrane. The cells have a transmembrane electrostatic potential that is increased above a resting potential upon application of the pulsed electric field. While the transmembrane electrostatic potential remains below a threshold potential, the electroporation is reversable, meaning the pores can close when the applied pulse electric field is removed, and the cells can self-repair and survive. If the transmembrane electrostatic potential increases beyond the threshold potential, the electroporation is irreversible, and the cells become permanently permeable. As a result, the cells die due to a loss of homeostasis and typically die by programmed cell death or apoptosis, which is believed to leave less scar tissue as compared to other ablation modalities. Generally, cells of differing types have differing threshold potential. For instance, heart cells have a threshold potential of approximately 500 V/cm, whereas for bone it is 3000 V/cm. These differences in threshold potential allow IRE to selectively target tissue based on threshold potential.
The solution of this disclosure includes systems and methods for applying electrical signals from catheter electrodes positioned in the vicinity of myocardial tissue, preferably by applying a pulsed electric field effective to induce electroporation in the myocardial tissue. The systems and methods can be effective to ablate targeted tissue by inducing irreversible electroporation. In some examples, the systems and methods can be effective to induce reversible electroporation as part of a diagnostic procedure. Reversible electroporation occurs when the electricity applied with the electrodes is below the electric field threshold of the target tissue allowing cells to repair. Reversible electroporation does not kill the cells but allows a physician to see the effect of reversible electroporation on electrical activation signals in the vicinity of the target location. Example systems and methods for reversible electroporation is disclosed inU.S. Patent Publication 2021/0162210, the entirety of which is incorporated herein by reference and attached in the appendix to priority application63/323,832.
The pulsed electric field, and its effectiveness to induce reversible and/or irreversible electroporation, can be affected by physical parameters of the system and biphasic pulse parameters of the electrical signal. Physical parameters can include electrode contact area, electrode spacing, electrode geometry, etc. examples presented herein generally include physical parameters adapted to effectively induce reversible and/or irreversible electroporation. Biphasic pulse parameters of the electrical signal can include voltage amplitude, pulse duration, pulse interphase delay, inter-pulse delay, total application time, delivered energy, etc. In some examples, parameters of the electrical signal can be adjusted to induce both reversible and irreversible electroporation given the same physical parameters. Examples of various systems and methods of ablation including IRE are presented inU.S. Patent Publications 2021/0169550A1,2021/0169567A1,2021/0169568A1,2021/0161592A1,2021/0196372A1,2021/0177503A1, and2021/0186604A1, the entireties of each of which are incorporated herein by reference and attached in the appendix to priority application63/323,832.
To deliver pulsed field ablation (PFA) in an IRE (irreversible electroporation) procedure, electrodes should contact the tissue being ablated with a sufficiently large surface area. As described hereinbelow, the medical probe includes a tubular shaft including proximal and distal ends, and a basket assembly at the distal end of the tubular shaft. The basket assembly includes a single unitary structure. The unitary structure can include a plurality of spines formed from a planar sheet of material and one or more electrodes coupled to each of the spines. The plurality of spines can converge at a central spine intersection including one or more cutouts. The cutouts can allow for bending of each spine such that the spines form an approximately spherical or oblate-spheroid basket assembly. It is noted that the cutouts (in various configurations described and illustrated in the specification) allows the basket to be compressed into a much smaller form factor when undeployed (or undergoing a retraction into a delivery sheath) without buckling or plastic deformation.
FIG. 1 is a schematic, pictorial illustration of amedical system 20 including amedical probe 22 and acontrol console 24, in accordance with an embodiment of the present invention.Medical system 20 may be based, for example, on the CARTO^® system, produced by Biosense Webster Inc. of 31 Technology Drive, Suite 200, Irvine, CA 92618 USA. In embodiments described hereinbelow,medical probe 22 can be used for diagnostic or therapeutic treatment, such as for performing ablation procedures in aheart 26 of apatient 28. Alternatively,medical probe 22 may be used, mutatis mutandis, for other therapeutic and/or diagnostic purposes in the heart or in other body organs.
Medical probe 22 includes aflexible insertion tube 30 and ahandle 32 coupled to a proximal end of the tubular shaft. During a medical procedure, a medical professional 34 can insertprobe 22 through the vascular system ofpatient 28 so that adistal end 36 of the medical probe enters a body cavity such as a chamber ofheart 26. Upondistal end 36 entering the chamber ofheart 26, medical professional 34 can deploy abasket assembly 38 approximate adistal end 36 of themedical probe 22.Basket assembly 38 can include a plurality ofelectrodes 40 affixed to a plurality ofspines 214, as described in the description referencingFIGs. 2A and 2B hereinbelow. To start performing a medical procedure such as irreversible electroporation (IRE) ablation, medical professional 34 can manipulate handle 32 to positiondistal end 36 so thatelectrodes 40 engage cardiac tissue at a desired location or locations. Upon positioning thedistal end 36 so thatelectrodes 40 engages cardiac tissue, the medical professional 34 can activate themedical probe 22 such that electrical pulses are delivered by theelectrodes 40 to perform the IRE ablation.
Themedical probe 22 can include a guide sheath and a therapeutic catheter, wherein the guide sheath includes theflexible insertion tube 30 and thehandle 32 and the therapeutic catheter includes thebasket assembly 38,electrodes 40, and a tubular shaft 84 (seeFIGs. 2 through 4). The therapeutic catheter is translated through the guide sheath so that thebasket assembly 38 is positioned in theheart 26. Thedistal end 36 of themedical probe 22 corresponds to a distal end of the guide sheath when thebasket assembly 38 is contained within theflexible insertion tube 30, and thedistal end 36 of themedical probe 22 corresponds to a distal end of thebasket assembly 38 when thebasket assembly 38 is extended from the distal end of the guide sheath. Themedical probe 22 can be alternatively configured to include a second handle on the therapeutic catheter and other features as understood by a person skilled in the pertinent art.
In the configuration shown inFIG. 1,control console 24 is connected, by acable 42, to body surface electrodes, which typically includeadhesive skin patches 44 that are affixed topatient 28.Control console 24 includes aprocessor 46 that, in conjunction with atracking module 48, determines location coordinates ofdistal end 36 insideheart 26. Location coordinates can be determined based on electromagnetic position sensor output signals provided from the distal portion of the catheter when in the presence of a generated magnetic field. Location coordinates can additionally, or alternatively be based on impedances and/or currents measured betweenadhesive skin patches 44 andelectrodes 40 that are affixed tobasket assembly 38. In addition to being used as location sensors during a medical procedure,electrodes 40 may perform other tasks such as ablating tissue in the heart.
As described hereinabove, in conjunction with trackingmodule 48,processor 46 may determine location coordinates ofdistal end 36 insideheart 26 based on impedances and/or currents measured betweenadhesive skin patches 44 andelectrodes 40. Such a determination is typically after a calibration process relating the impedances or currents to known locations of the distal end has been performed. While embodiments presented herein describeelectrodes 40 that are preferably configured to deliver IRE ablation energy to tissue inheart 26, configuringelectrodes 40 to deliver any other type of ablation energy to tissue in any body cavity is considered to be within the spirit and scope of the present invention. Furthermore, although described in the context of beingelectrodes 40 that are configured to deliver IRE ablation energy to tissue in theheart 26, one skilled in the art will appreciate that the disclosed technology can be applicable to electrodes used for mapping and/or determining various characteristics of an organ or other part of the patient's 28 body.
Processor 46 may include real-timenoise reduction circuitry 50 typically configured as a field programmable gate array (FPGA), followed by an analog-to-digital (A/D) signal conversion integratedcircuit 52. The processor can be programmed to perform one or more algorithms and usescircuitry 50 andcircuit 52 as well as features of modules to enable the medical professional 34 to perform the IRE ablation procedure.
Control console 24 also includes an input/output (I/O)communications interface 54 that enablescontrol console 24 to transfer signals from, and/or transfer signals toelectrodes 40 andadhesive skin patches 44. In the configuration shown inFIG. 1,control console 24 additionally includes anIRE ablation module 56 and aswitching module 58.
IRE ablation module 56 is configured to generate IRE pulses including peak power in the range of tens of kilowatts. In some examples, theelectrodes 40 are configured to deliver electrical pulses including a peak voltage of at least 900 volts (V). Themedical system 20 performs IRE ablation by delivering IRE pulses toelectrodes 40. Preferably, themedical system 20 delivers biphasic pulses betweenelectrodes 40 on the spine. Additionally, or alternatively, themedical system 20 delivers monophasic pulses between at least one of theelectrodes 40 and a skin patch.
In order to dissipate the heat and to improve the efficiency of the ablation process,system 20 supplies irrigation fluid (e.g., a saline solution) todistal end 36 and to theelectrodes 40 via a channel (not shown) in tubular shaft 84 (seeFIGs. 2A through 2C). Additionally, or alternatively, irrigation fluid can be supplied through theflexible insertion tube 30.Control console 24 includes anirrigation module 60 to monitor and control irrigation parameters, such as the pressure and the temperature of the irrigation fluid. It is noted that while the preference for the exemplary embodiments of the medical probe is for IRE or PFA, it is within the scope of the present invention to also use the medical probe separately only for RF ablation (unipolar mode with an external grounding electrode or bipolar mode) or in combination with IRE and RF ablations sequentially (certain electrodes in IRE mode and other electrodes in RF mode) or simultaneously (groups of electrodes in IRE mode and other electrodes in RF mode).
Based on signals received fromelectrodes 40 and/oradhesive skin patches 44,processor 46 can generate anelectroanatomical map 62 that shows the location ofdistal end 36 in the patient's body. During the procedure,processor 46 can presentmap 62 to medical professional 34 on adisplay 64, and store data representing the electroanatomical map in amemory 66.Memory 66 may include any suitable volatile and/or non-volatile memory, such as random-access memory or a hard disk drive.
In some embodiments, medical professional 34 can manipulate map 62 using one ormore input devices 68. In alternative embodiments,display 64 may include a touchscreen that can be configured to accept inputs from medical professional 34, in addition to presentingmap 62.
FIG. 2A is a schematic pictorial illustration showing a perspective view of amedical probe 22 including abasket assembly 38 in an expanded form when unconstrained, such as by being advanced out of aninsertion tube lumen 37 at adistal end 36 of aninsertion tube 30. Themedical probe 22 illustrated inFIG. 2A lacks the guide sheath illustrated inFIG. 1.FIG. 2B shows the basket assembly in a collapsed form withininsertion tube 30 of the guide sheath. In the expanded form (FIG. 2A),spines 214 bow radially outwardly and in the collapsed form (FIG. 2B) the spines are arranged generally along alongitudinal axis 86 ofinsertion tube 30.
As shown inFIG. 2A,basket assembly 38 includes a plurality offlexible spines 214 that are formed at the end of atubular shaft 84 and are connected at both ends. During a medical procedure, medical professional 34 can deploybasket assembly 38 by extendingtubular shaft 84 frominsertion tube 30 causingbasket assembly 38 to exitinsertion tube 30 and transition to the expanded form.Spines 214 may have elliptical (e.g., circular) or rectangular (that may appear to be flat) cross-sections, and include a flexible, resilient material (e.g., a shape-memory alloy such as nickel-titanium, also known as Nitinol) forming a strut as will be described in greater detail herein.
As shown inFIG. 2A, the plurality offlexible spines 214 converge at acentral spine intersection 211. In some examplescentral spine intersection 211 can include one ormore cutouts 212 that allow for bending of thespines 214 when each spinerespective attachment end 216 is connected to thespine retention hub 90, described in more detail below.
In embodiments described herein, one ormore electrodes 40 positioned on spines 114 ofbasket assembly 38 can be configured to deliver ablation energy (RF and/or IRE) to tissue inheart 26. Additionally, or alternatively, the electrodes can also be used to determine the location ofbasket assembly 38 and/or to measure a physiological property such as local surface electrical potentials at respective locations on tissue inheart 26. Theelectrodes 40 can be biased such that a greater portion of the one ormore electrodes 40 face outwardly frombasket assembly 38 such that the one ormore electrodes 40 deliver a greater amount of electrical energy outwardly away from the basket assembly 38 (i.e., toward theheart 26 tissue) than inwardly.
Examples of materials ideally suited for formingelectrodes 40 include gold, platinum and palladium (and their respective alloys). These materials also have high thermal conductivity which allows the minimal heat generated on the tissue (i.e., by the ablation energy delivered to the tissue) to be conducted through the electrodes to the back side of the electrodes (i.e., the portions of the electrodes on the inner sides of the spines), and then to the blood pool inheart 26.
As shown inFIGs. 2A and 2B,basket assembly 38 has adistal end 39. Themedical probe 22 can include aspine retention hub 90 that extends longitudinally from a distal end oftubular shaft 84 towardsdistal end 39 ofbasket assembly 38. As described supra,control console 24 includesirrigation module 60 that delivers irrigation fluid tobasket assembly 38 throughtubular shaft 84.
Turning toFIG. 2C,basket assembly 38 includes a single unitary structure that includes a plurality ofspines 214 formed from a planar sheet of material 210 (shown more clearly inFIGs. 9 and10A). Thespine retention hub 90 can be inserted into thetubular shaft 84 and attached to thetubular shaft 84.Spine retention hub 90 can include acylindrical member 94 including a plurality of relief lands 96, anirrigation hub 97,multiple irrigation openings 98, and at least one spine retention hub electrode 99, or some combination thereof. Relief lands 96 can be disposed on the outer surface ofcylindrical member 94 and configured to allow a portion of eachspine 214, such as eachspine attachment end 216, to be fitted into arespective relief land 96. In particular, eachspine attachment end 216 can include aneyelet 216a as well as one ormore locators 216b.Eyelet 216a andlocators 216b can be provided to aid in assembly as well as physical retention of the spines to thetubular member 84 through the relief lands 96.
Theattachment end 216 can be a generally linear end of thespine 214. Theattachment end 216 can be configured to extend outwardly from thespine retention hub 90 such that thebasket assembly 38 is positioned outwardly from thespine retention hub 90 and, consequently, outwardly from thetubular shaft 84. In this way, thespine 214 can be configured to position thebasket assembly 38 distally from the distal end of thetubular shaft 84 and distal from the distal end of theinsertion tube 30 when the basket assembly is deployed.
As described supra,control console 24 includesirrigation module 60 that delivers irrigation fluid todistal end 36. Themultiple irrigation openings 98 can be angled to spray or otherwise disperse of the irrigation fluid to either a givenelectrode 40 or to tissue inheart 26. Sinceelectrodes 40 do not include irrigation openings that deliver irrigation fluid, the configuration described hereinabove enables heat to be transferred from the tissue (i.e., during an ablation procedure) to the portion of the electrodes on the inner side of thespines 214, and theelectrodes 40 can be cooled by aiming the irrigation fluid, viairrigation openings 98, at the portion of theelectrodes 40 on the inner side of thespines 214. Spine retention hub electrode 99 disposed at a distal end ofretention hub 90 can be used in combination withelectrodes 40 on thespines 214, or alternatively, can be used independently fromelectrodes 40 for reference mapping or ablation.
FIG. 2D is an exploded view forcontact force sensor 400 referenced inFIG. 2C. As shown inFIG. 2D, thecontact force sensor 400 is disposed inside tube 84 (not shown inFIG. 2D) and proximally in relation to thebasket assembly 38 and as close as possible to thebasket 38 so that contact with cardiac tissue by thespines 214 can be transmitted to thecontact force sensor 400.Contact force sensor 400 includescoupler 414 provided with a plurality ofnotches 414a, 414b, 414c on the periphery of the cylindrical member orcoupler 414 for corresponding engagement withprotrusions 194a, 194b, 194c ofbeam coupling member 190. A spine retention hub orcoupler 90 is provided withnotches 416a, 416b, 416c that mate withprotrusions 192a, 192b, 192c ofbeam coupling member 190.Flat surfaces 416d of spine retention hub or coupler 90 (angled with respect toaxis 86 for spine retention hub or coupler 90) are formed whereby eachflat surface 416d is angulated with respect to theaxis 86 so that each flat surface is complementary to the angulation ofbeam coupling member 190 defined by the helicoid path of protrusions 194a, 194b, 194c (i.e., helix angle). Three flat surfaces (not shown due to the perspective view) 414d ofcontact force sensor 400 are also provided forcoupler 414 in a configuration similar toflat surface 416d of spine retention hub orcoupler 90 in that the threeflat surfaces 414d are also angulated with respect to theaxis 86 so that eachflat surface 414d ofcoupler 414 are generally parallel to the angulation path ofbeam coupling member 190 defined by the helicoid ramp of protrusions 194a-194c as well asflat surface 416d.
The location sensor coils 422 and 424 are mounted to coupler 414 (for coupling with hub 96) in a generally equiangular configuration about theaxis 86. It is noted that while two coils (for X and Y axes) are used in an exemplary embodiment to determine the location of these coils (as mounted to thecoupler 414 and thereby the location of the basket spines as the distance between basket spines and the location sensor is known), in certain circumstances, only one location sensing coil may be utilized if the other two axes are known via other visualization techniques. As well, three location sensing coils may also be used depending on the packaging constraints of the catheter. Details of the contact force sensor are provided inU.S. Patent Application Publication No. 20210077180A1 published March 18, 2021, which disclosure is incorporated herein by reference and attached in the appendix to priority application63/323,832.
FIG. 3A is a perspective view of abasket assembly 38 in an expanded form with the plurality offlexible spines 214 converging at thecentral spine intersection 211 having asingle cutout 212. Eachspine 214 can include a plurality ofelectrodes 40. As shown, eachspine 214 can be insulated from therespective electrode 40 by aninsulative jacket 80 covering at least a portion of thespine 214. In addition, each spine can further include aframe extrusion 70, shown more clearly inFIG. 5B.Frame extrusion 70 can function to maintain the position of theinsulative jacket 80 andelectrode 40 by preventing theinsulative jacket 80 from slipping or moving about thespine 214 during deployment.Frame extrusion 70 can also function to insulate theelectrode 40 from thespine 214.
FIG. 3B illustrates a cross-sectional view of arespective spine 214,insulative jacket 80, andelectrode 40 ofFIG. 3A. In some examples,electrode 40 can have a substantially circular or oval cross-sectional shape matching that ofinsulative jacket 80, while thespines 214 can have a substantially rectangular cross-sectional shape.Insulative jacket 80 can also include a substantially rectangular opening such thatrespective spine 214 can extend through theinsulative jacket 80. As shown inFIG. 3B,electrode 40 can include an electrode body thickness T1 that is substantially similar to a spine thickness T2. In some examples, the plurality ofspines 214 can have a cross-sectional thickness of about 0.05mm (0.002") to about 0.15mm (0.006") Eachelectrode body 40 can have a wall cross-sectional thickness of about 0.03mm (0.001") to about 0.13mm (0.005"). Eachelectrode body 40 can have a wall cross-sectional thickness of about 0.1mm (0.004") to about 0.3mm (0.012").
Referring back toFIG. 2A through FIG. 2C, one ormore electrodes 40 can be attached tospines 214 to form thebasket assembly 38. In some examples, eachelectrode 40 can include electrically conductive material (e.g., gold, platinum and palladium (and their respective alloys)).
Turning toFIGs. 4A through 4C,electrode 40 can have a variety of cross-sectional shapes, curvatures, lengths, lumen number and lumen shape. Theelectrode 440 is offered to illustrate one various configuration ofelectrodes 40 that can be used with themedical device 22 but should not be construed as limiting. One skilled in the art will appreciate that various other configurations ofelectrodes 40 can be used with the disclosed technology without departing from the scope of this disclosure.
Eachelectrode 440 can have anouter surface 474 facing outwardly fromelectrode 440 and aninner surface 476 facing inwardly towardelectrode 440 where at least onelumen 470 is formed throughelectrode 440. Thelumen 470 can be sized and configured to receive aspine 214 such thatspine 214 can pass throughelectrode 440.Lumen 470 can be a symmetric opening throughelectrode 440 and can be disposed offset with respect to acentral axis 87 of the respective electrode. In other examples,lumen 470 can pass throughelectrode 440 in a generally transverse direction with respect to thecentral axis 87 of the respective electrode. Furthermore,lumen 470 can be positioned inelectrode 440 nearer a bottom surface, nearer a top surface, or nearer a middle ofelectrode 440 depending on the particular configuration. InFIGs. 4A and 4B, the top surface (upper side) is oriented toward the top of the drawing, the bottom surface (lower side) is oriented toward the bottom of the drawing, and the middle is between the top surface and the bottom surface. In other words, eachelectrode 440 can include alumen 470 that is offset with respect to a centroid of theelectrode 440.
In addition, as shown inFIGs. 4A through 4C,electrodes 440 can have alumen 470 large enough for arespective spine 214 and a wire to pass through the electrode such that theelectrode 440 can be in electrical communication with thecontrol console 24. Although not shown,electrodes 440 can also include a wire relief forming a recess or depression inelectrode 440adjacent lumen 470 for one or more wires to pass throughlumen 470 along with arespective spine 214. Relief can be sized to provide room for a wire ofelectrode 440 to pass throughelectrode 440 such thatelectrode 440 can be in electrical communication with thecontrol console 24.
Alternatively, or in addition thereto, wires can pass through a wire lumen. Although not depicted,electrodes 40 may include both a wire reliefadjacent lumen 470 and wire lumen. Such electrode may permit additional wires to pass through the electrode body.
As shown inFIGs. 4A-4C, theelectrodes 440 can include a cross-sectional shape that is substantially circular or oval. In particular,electrodes 440 can include afirst section 441A and asecond section 441B that define a lengthwise direction of theelectrode 440 and join together to form a substantially circular shape. The twosections 441A, 441B can each independently be a half circle or half oval shape curving inward with respect to thecentral axis 87 of therespective electrode 440. Although not illustrated, the twosections 441A, 441B can be of independent lengths or curvatures such that the dimensions of the respective electrode can be more circular, as shown inFIG. 4A, or more oval or substantially flattened on either thefirst section 441A or thesecond section 441B.
FIGs. 5A and 5B are schematic pictorial illustrations showing variousinsulative jackets 580A-580C of a givenmedical device 22, in accordance with embodiments of the present invention.FIG. 5A is a front view whileFIG. 5B is a perspective view ofinsulative jacket 580C.Insulative jackets 580A-580C can be made from a biocompatible, electrically insulative material such as polyamide-polyether (Pebax) copolymers, polyethylene terephthalate (PET), urethanes, polyimide, parylene, silicone. In some examples, insulative material can include biocompatible polymers including, without limitation, polyetheretherketone (PEEK), polyglycolic acid (PGA), poly(lactic-co-glycolic acid) copolymer (PLGA), polycaprolactive (PCL), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), poly-L-lactide, polydioxanone, polycarbonates, and polyanhydrides with the ratio of certain polymers being selected to control the degree of inflammatory response.Insulative jackets 580A-580C may also include one or more additives or fillers, such as, for example, polytetrafluoroethylene (PTFE), boron nitride, silicon nitride, silicon carbide, aluminum oxide, aluminum nitride, zinc oxide, and the like.Insulative jacket 580A-580C can help to insulate aspine 214 and/or wires passing throughinsulative jacket 580A-580C fromelectrode 40 to prevent arcing fromelectrode 40 to thespine 214 and/or mechanical abrasion of wires passing throughinsulative jacket 580A-580C.
As illustrated inFIGs. 5A and 5B,insulative jackets 580A-580C, can include a cross-sectional shape that is substantially circular or oval. The insulative jacket may consist of a single lumen (as shown inFIG. 5B) or multi-lumen configuration (depicted inFIG. 5A). Multi-lumen jackets may be configured such that the alloy frame and wires share a single lumen while the second lumen may be used for irrigation. The alloy frame and wires may occupy separate lumens, also, as described. The current embodiment does not utilize irrigated jackets. For these designs, the insulative jackets may be continuous (individual sleeves extending from proximal to distal end of each alloy frame strut), segmented (bridging between electrode gaps), or a combination of both. Furthermore,insulative jacket 580A, 580B can include afirst lumen 582A, 582B and asecond lumen 584A, 584B, whileinsulative jacket 580C includes only afirst lumen 582C. In one configuration,first lumen 582A, 582B can be configured to receivespine 214 whilesecond lumen 584A, 584B can be configured to receive a wire, or vice-versa. In other examples,first lumen 582A-582C can each be configured to receivespine 214 in addition to one or more wires that can be connected to one ormore electrodes 40. Furthermore, as illustrated inFIG. 5B,insulative jacket 580A-580C can include anaperture 586 through which a wire can be electrically connected toelectrode 40. Although illustrated inFIG. 5B as being proximate a bottom ofinsulative jacket 580C,aperture 586 can be positioned proximate a top or side ofinsulative jacket 580C. Furthermore, as shown inFIG. 5B,insulative jacket 580C can includemultiple apertures 586 with each aperture being disposed on the same side of insulative jacket (i.e., top, bottom, left, right) or on different sides of the insulative jacket depending on the application. As shown inFIG. 5B, frame extrusion 570 can function to maintain the position of the insulative jacket 580 and electrode (not pictured) by preventing theinsulative jacket 580C from slipping or moving about the spine during deployment.
As illustrated inFIG. 5C, frame extrusion 570 can be composed of two segments, including adistal frame extrusion 570A proximate thecentral intersection 211 of the basket assembly and aproximal frame extrusion 570B proximate the spine attachment ends 216. Frame extrusion 570 with two segments may improve bonding and mechanical performance ofbasket assembly 38. In addition, frame extrusion 570 can provide electrical insulation between the spines 114 andelectrodes 40. Frame extrusion 570 having twosegments 570A, 570B with no frame extrusion extending over the center of a relative spine 114 may allow for greater flexibility and shape retention of thebasket assembly 38. Although not depicted, frame extrusion 570 can be a single component that extends along the entire length of the respective spine. In some examples, frame extrusion 570 may be uncoated or coated with materials including silicone, urethane, parylene, polyether block amide (e.g., known under the tradename of PEBAX (Arkema) and VESTAMID E (Evonik Industries)), or polyethylene terephthalate. The coating can extend along at least a portion of the frame extrusion 570 or over a portion of eachsegment 570A, 570B. The coating can also extend along the entire length of the frame extrusion 570 and/or along the entire length of eachsegment 570A, 570B. The coating may be composed of a heat shrink material for generating very thin wall thicknesses. The coating may provide further electrical insulation as well as providing a bondable surface that is less prone to slip. In some examples, frame extrusion 570 may be composed of a number of layers, including a number of full-length extrusions combined with one or more segmented (proximal and distal end) extrusions. In certain examples, a full-length extrusion can be patient contacting and may additionally include a secondary or tertiary layer depending on the construction.
FIG. 5D provides a schematic pictorial illustration showing a respectivedistal frame extrusion 570A positioned proximate thecentral intersection 211.Distal frame extrusion 570A can have a substantially circular cross-sectional shape with aproximal lumen 572A sized to loosely fit thespine 214 therethrough.Distal frame extrusion 570A can also include adistal lumen 572B sized to tightly fit thespine 214 through. In some examples, thedistal lumen 572B of thedistal frame extrusion 570A tapers inward with respect to acentral axis 87 about thespine 214 and forms a substantially rectangular cross-sectional opening sized to tightly fit thespine 214 and prevent slippage along thespine 214.
FIGs. 5E through 5G provide schematic pictorial illustrations offrame extrusion fixtures 573A, 573B positioned on aspine 214 to provide alignment of frame extrusion 570 and/or insulative jacket 580. Eachrespective spine 214 may have one or more ofridges 573A or throughholes 573B added to thespine 214 through laser cutting or other suitable methods.Spines 214 having either one or both ofridges 573A and/or throughholes 573B can improve adhesive bonding as well as improve mechanical retention of the frame extension 570. Gaps betweenridges 573B of a certain length can help minimize "bridging" of the extrusion between ridge peaks. Although not depicted, each distal frame extrusion 570 can provide a notch internal thedistal lumen 572B of thedistal frame extrusion 570A that is configured to interact with the one or more cutouts extending along the length of thespine 214, shown inFIGs. 7A-7E.
FIGs. 6A and 6B are schematic pictorial illustrations showing cross-sectional views of a givenwire 600, 650 that can be connected to a givenelectrode 40, in accordance with an embodiment of the present invention.FIG. 6A illustrates asolid core wire 600.FIG. 6B illustrates a strandedwire 650. Eachwire 600, 650 can extend through at least a portion oftubular shaft 84 andtubular shaft 84.Solid core wire 600 can include an electricallyconductive core material 602 and an electricallyconductive cover material 604 circumscribing electricallyconductive core material 602. Likewise, strandedwire 650 can include strands each including an electricallyconductive core material 652 and an electricallyconductive cover material 654 circumscribing the electricallyconductive core material 652. Eachwire 600, 650 can include aninsulative jacket 606 circumscribing the conductors. Thewires 600, 650 can be configured to withstand a voltage difference of adjacent wires sufficient to deliver IRE pulses. Preferably, thewires 600, 650 can withstand at least 900V, and more preferably at least 1,800V between adjacent wires. To reduce likelihood of dielectric breakdown between conductors of adjacent wires, electricallyconductive cover material 604, 654 can have a lower electrical conductivity compared tocore material 602, 652.
Insulative jacket 606 can be configured to have a temperature rating between 150 and 200 degrees Centigrade so that the electricallyinsulative jacket 606 melts or degrades (e.g., chars and crumbles) during soldering ofwire 600 to electrodes 40 (e.g., at a temperature of 300 degrees Centigrade) and thereforeinsulative jacket 606 ofwire 600 does not need to be mechanically stripped. In other examples,insulative jacket 606 can have a temperature rating greater than 200 degrees Centigrade to prevent electrically insulatingmaterial 602 melting or degrading (e.g., charring and crumbling) during manufacture ofmedical probe 22 and/or during use.Insulative jacket 606 can be mechanically stripped fromwire 600 prior towires 600 being electrically connected toelectrodes 40.
FIGs. 7A through 7E are schematic pictorial illustrations of top-down views ofbasket assembly 38, showing various examples of one ormore cutouts 212 oncentral spine intersection 211. As shown,intersection 211 can include a singlediscrete cutout 212A, as shown inFIGs. 7A and7B. Alternatively,intersection 211 can include two ormore cutouts 212B, as provided as an example inFIGs. 7C and7D. The one ormore cutouts 212A, 212B can include a variety of patterns, such as centrosymmetric (i.e., symmetric with respect to a central point), and equiangular (i.e., including equal angles) to allow for equal bending among thespines 214 as well as disproportional and asymmetric to allow for unequal bending ofspines 214 to alter structural stability. In certain instances, whenbasket assembly 38 includes an even number ofspines 214, the pattern of the one ormore cutouts 212 can alter between every other spine, as illustrated inFIG. 7B. In some examples, one ormore cutouts 212 can extend along a portion of eachspine 214. Each of the designs illustrated inFIGS. 7A-7E will be discussed separately.
InFIG. 7A, the distal end of thebasket assembly 38 has anopen cutout 212 which is a combination of acentral opening 212A (substantially approximated by avirtual circle 213 with diameter D1) and thegroove 212B for each spine (giving a total of sixgrooves 212B). Each spine is disposed generally equiangularly about the longitudinal axis of a predetermined angle α between any two spines. Eachgroove 212B has groove width S that extend approximately a length L1 from the circumference of virtual circle D1 so that avirtual circle 215 with diameter D2 is contiguous to thegrooves 212B. The secondvirtual circle 215 has a diameter D2 approximately 3.6 times that of the diameter D1 of the firstvirtual circle 213. In one embodiment, the cutout 212 (represented bycenter cutout 212A andopen grooves 212B) has a negative area of about 1.9 mm² with the diameter of thevirtual circle 213 of about 1.1 mm and thevirtual circle 215 of about 4mm such that eachopen groove 212B has a width S of about 0.08mm extending for about 1.5mm from thevirtual circle 213 so that the negative area defined by all the cutouts in this design includes approximately 1.9mm².
InFIG. 7B, thebasket 38 has its distal portion configured to have anopen center 212A that radiates into each of the sixspines 214. Theopen center 212A has a first area A1 that can be approximated by a virtual circle with radius r1. Three spines approximately 120 degrees apart have taperinggrooves 212B extending back toward the proximal portion ofbasket 38. Three other spines approximately 120 degrees apart havelarge apertures 217 with area A3 disposed towards the proximal portion of thebasket 38. The cutout area A3 can be approximated by a virtual circle with radius r3 and disposed on thespines 214 such that theapertures 217 are contiguous to the inside circumference ofvirtual circle 215 with radius r2. In this configuration, each third area A3 is about 1/4 of the open first area A1 while the total negative surface area of the entire cutout includes approximately 1.6 times the first open area of empty space A1 and the second area A2 (calculated with radius r2) includes approximately 7 times the first area A1. Additionally, the second area A2 includes approximately 36 times third area A3. The radius r3 includes approximately 0.4 times that of radius r1 while radius r2 includes approximately 2.8 times that of radius r1. In one exemplary embodiment, first open area of empty space A1 includes approximately 2 mm²; second area A2 (as defined by radius r2) being approximately 15mm²; third area A3 includes approximately 0.4 mm²; total area of all cutouts includes approximately 3.5 mm²; radius r1 ~ 0.8mm; r2 ~2.2mm; and r3 ~0.4mm.
InFIG. 7C, this design has asmall aperture 212A disposed at the center (coincident with longitudinal axis 86) of thebasket 38 with a tadpole shapedcutout 211 disposed on each of thespines 214. Eachtadpole cutout 211 is defined by anaperture cutout 212B that is merged withgrooved cutout 212C. It is noted that whileaperture 212A or 212B is shown approximating the of a circle, it is within the scope of this invention to havecutout opening 212A or 212B in any shape as long as eachaperture 212A or 212B has the requisite negative area. In the event theaperture 212A is configured as a circle,aperture 212A has central void A0(of negative area) that can be approximated by a first virtual circle with radius r0 while eachaperture 212B has a second area A2 that can be represented by a second virtual circle with radius r2. Theapertures 212B (or the "heads" of the tadpole cutouts) are radially arrayed so thatapertures 212B are contiguous to a first virtual circle with radius r1. The second virtual circle may have a second radius r2 of 1.2 times that of the radius r0 of the first virtualcircle representing aperture 212A while the first virtual circle r1 may have radius r1 of approximately 1.5 times that of the radius of the central virtual circle r0. The tail orgrooved opening 212C of the "tails" extends towards the proximal end of thebasket 38 for a length L1 so that each tail is contiguous to an inside circumference of a thirdvirtual circle 215. Slot length L1 includes approximately 6-10 times that of the first radius r1. Thirdvirtual circle 215 may have a radius r3 extending from thelongitudinal axis 86 where radius r3 includes approximately 10-15 times that of either first radius r1 or central radius r0. In the exemplary embodiment (amongst many), the negative area of each of thetadpole cutout 211 includes approximately 0.2 mm² while the negative area ofcenter aperture 212A includes approximately 0.05mm² so that the total negative area defined by all of the cutouts includes approximately 1.4mm². In the same exemplary embodiment, the central radius r0 may be approximately 0.13mm, the second radius r2 may be approximately 0.2mm, and the first radius r1 may be approximately 0.23mm.
InFIG. 7D, the design of thebasket 38 is provided with anaperture 212A at approximate center (i.e., axis 86) of thespines 214. Eachspine 214 is provided a comet-shapedcutout 211 withhead portion 212B with an open taperedslot tail 212C tapering towards the proximal portion of eachspine 214. The comet-shapedcutouts 212B are arrayed so that thedistal head portion 212B of thecutout 211 are contiguous to an outside circumference of secondvirtual circle 213 while the proximal slottedopening 212C of thecutouts 211 are contiguous on the inside circumference of thirdvirtual circle 215. Where theaperture 212A is configured as a circular hole located oncentral axis 86 with radius r0 where the first radius r1 includes approximately 90% of the central radius r0, the secondvirtual circle 213 may have a second radius r2 of approximately 2.5 times that of central radius r0 while the thirdvirtual circle 215 has a radius r3 of approximately 10 times that of the central radius r0 (all measured from center axis 86).Spine 214 has a first width W1 that tapers towardscentral axis 86 to a narrower second spine width W2 of approximately 66% of first spine width W1 at its narrowest point before being sub-divided by comet shapedcutout 212B into two narrower spine arms with each arm including a third spine width W3 of approximately 1/3 that of the width W1. The comet shapedcutout 212B has a length L1 along the spine of approximately 1.8 times that of the largest spine width W1.
InFIG. 7E, the center (on longitudinal axis 86) of the radiatingspines 214 forbasket 38 does not have a cutout so that there is no void at the center of the basket to act as sharp edge surface (at the edge of such center aperture) against biological tissues. To allow for consistent folding of the spines near the distal portion ofbasket 38, each spine is provided with a tadpole shapedcutout 211 that extends from thehead portion 212B totail portion 212C. Thehead portions 212B are arrayed so that thehead portions 212B are contiguous to an outside circumference of firstvirtual circle 213 with radius r1. Eachhead portion 212B has a negative surface area that can be approximated by a second virtual circle with radius r2 of approximately 90% of the first radius r1. Thetail portions 212C are bounded by a thirdvirtual circle 215 with a radius r3 approximately 10 times that of the first radius. The length L1 of each of the tail portion includes approximately 1.5 times that of the width W1 of thespine 214. In one exemplary embodiment (out of many), the total negative area of the six cutouts includes approximately 1.5 mm².
Thespines 214 can be folded or otherwise bent such that each respective attachment end 216 of thespine 214 can be inserted into thedistal end 85 of the tubular shaft 84 (as shown inFIG. 2B) andrelief lands 96 of spine retention hub 90 (not shown). Although not shown inFIGs. 10A and 10B, it will be appreciated thatelectrodes 40 can be attached tospines 214 before the spines are inserted into thetubular shaft 84 to form thebasket assembly 38. As stated previously, thespines 214 can include a flexible, resilient material (e.g., a shape-memory alloy such as nickel-titanium, also known as Nitinol) that can enable thebasket assembly 38 to transition to its expanded form (as shown inFIG. 2A) when thebasket assembly 38 is deployed fromtubular shaft 84. As will become apparent throughout this disclosure,spines 214 can be electrically isolated fromelectrode 40 to prevent arcing fromelectrode 40 to therespective spine 214.
As will be appreciated by one skilled in the art with the benefit of this disclosure,basket assembly 38 shown inFIGs. 2A through2C including spines 214 formed from a single sheet of planar material and converging at a central intersection is offered merely for illustrative purposes and the disclosed technology can be applicable to other configurations ofbasket assemblies 38. For example, the described configuration of the basket spine assemblies can be obtained via laser cutting a nitinol tube and heat treating the spines from the tubular stock into substantially the planar form shown herein. As well, the disclosed technology can be applicable tobasket assemblies 38 formed from asingle spine 214 ormultiple spines 214 with eachspine 214 being attached at both ends. In other examples, thebasket assembly 38 can include a central hub connecting themultiple spines 214 together at adistal end 39 of thebasket assembly 38. In yet other examples, thebasket assembly 38 can include asingle spine 214 configured to form a spiral,multiple spines 214 configured to form a spiral,multiple spines 214 configured to form a tripod or multiple tripods, or any other shape ofbasket assembly 38. Thus, althoughFIGs. 2A through 2C illustrate a specific configuration ofbasket assembly 38, the disclosed technology should not be construed as so limited.
In the exemplary embodiments shown herein, the spines width W may have a nominal width of approximately 0.6 mm and can be as low as 0.2 mm or as large as 1.5 mm. The thickness of each spine can be nominally 0.09 mm and can vary from 0.05mm to 0.2mm. It should be noted that these values for width and thickness can vary depending on the stiffness desired.
FIGs. 8A and 8B are schematic pictorial illustrations showing a profile outline of abasket assembly 38A, 38B such that when the basket assembly is deployed the spines define a three-dimensional shape including the profile. The basket assembly can be approximately spheroid including an approximately circular profile as shown inFIG. 8A. The basket assembly can have an approximately oblate-spheroid shape including an approximately elliptical profile as shown inFIG. 8B. Although not every variation of shape is shown or described herein, one skilled in the art will appreciate thatspines 214 can be further configured to form other various shapes as would be suitable for the particular application.
By includingspines 214 configured to form various shapes when in the expanded form,basket assembly 38 can be configured to position thevarious electrodes 40 attached tospines 214 at various locations, with each location being nearer or farther from the distal end oftubular shaft 84. For example,electrode 40 attached tospine 214 illustrated inFIG. 8A near the middle ofspine 214 would be farther from the distal end oftubular shaft 84 thanspine 214 illustrated inFIG. 8B whenbasket assembly 38 is in the expanded form. In addition, eachspine 214 may have an elliptical (e.g., circular) or rectangular (that may appear to be flat) cross-section, and include a flexible, resilient material (e.g., a shape-memory alloy such as nickel-titanium (also known as Nitinol), cobalt chromium, or any other suitable material).
FIGs. 9,10A and 10B are schematic pictorial illustrations showing views ofspines 214 formingbasket assembly 38.FIG. 9 provides one example of how planar sheet ofmaterial 210 may be assembled together withtubular shaft 84 whereby eachspine 214 bends or curves when respective attachment ends 216 are connect tospine retention hub 90. As shown inFIG. 10A, thespines 214 can be formed from a single sheet ofplanar material 210 to form a generally star shape. In other words,spines 214 can be formed from the single sheet of planar material such that thespines 214 converge toward acentral intersection 211. Theintersection 211 can be a solid piece of material (as shown inFIG. 10A) or include one or more cutouts 212 (as shown inFIG. 10B).Basket assembly 38 can include a number ofspines 214 ranging from about four to about ten spines from a single sheet ofplanar material 210.
Thespine assembly 210 can be physically connected to thetubular member 84 via a suitable technique such as adhesive or molding. In one embodiment shown here inFig. 10C,eyelet 216a as well aslocators 216b can be provided to aid in assembly as well as physical retention of the spines to thetubular member 84.
Where it is desired, a balloon BL can be provided as shown inFig. 10D inside the spine assembly 210' to ensure full expansion of the spine assembly 210' from a cylindrical form factor into a spheroidal form as shown inFig. 10C. The balloon BL can include a polymer material. In the embodiment ofFig. 10C, the spine assembly can be made from a tubular cylindrical stock material so that theproximal portion 210A anddistal portion 210B are of one-piece material. The tubular stock is cut into a desired shape for the spine assembly 210' as shown inFig. 10E. Thereafter, the cut tube can be shape set (or heat set) as is known by those skilled in the art to provide for the spheroidal spine configuration shown inFig. 10F.
FIG. 11 is a flowchart illustrating amethod 1100 of manufacturing abasket assembly 38, in accordance with an embodiment of the present invention.Method 1100 can include aligning 1102 a spine of anexpandable basket assembly 38 with anelectrode 40. The electrode can include an electrode body defining a lumen therethrough such that therespective spine 214 extends through the electrode body. The electrode body can include a substantially circular cross-sectional shape.Method 1100 can include inserting 1104 each spine into a lumen of at least oneelectrode 40. Theelectrodes 40 can be positioned such that the electrodes are offset betweenelectrodes 40 onadjacent spines 214.Method 1100 can include fitting 1106 ends of thespine 216 to atubular shaft 84 sized to traverse vasculature such that thecentral spine intersection 211 is positioned at adistal end 39 of themedical probe 22 and respective spines are movable from a tubular configuration to a bowed configuration. As will be appreciated by one of skill in the art including the benefit of this disclosure, fitting 1106 an end of the spine into a tubular shaft can include attaching thespine 214 to aspine retention hub 90. Furthermore, thespine retention hub 90 and/or thespine 214 and thetubular shaft 84 can be inserted into aflexible insertion tube 30 to form themedical probe 22
In some examples, the method can also include forming an approximately spheroid or oblate-spheroid shape with the spines.Method 1100 can further include electrically connecting the wire to the one or more electrodes.Method 1100 can also include disposing an insulative jacket over a spine having a substantially rectangular cross-sectional shape. The electrically insulative jacket can include a body defining an opening having a substantially rectangular cross-sectional shape such that the respective spine can extend therethrough.
Method can also include cutting a planar sheet ofmaterial 210 to form a plurality ofspines 214 including acentral spine intersection 211. Cutting the plurality ofspines 214 can include cutting from a pattern including longitudinal and transverse scores. The planar sheet of resilient material can include shape-memory alloy such as nickel-titanium (also known as Nitinol), cobalt chromium, or any other suitable material.Method 1100 can include cutting adiscrete cutout 212 at thecentral spine intersection 211. As described supra, thediscrete cutout 212 can be a single cutout or two or more cutouts. In addition, the one or more discrete cutouts can be cut in a pattern to extend along at least a portion of each spine. In some examples, steps may occur as simultaneous steps or as a sequence of steps. As an alternative, metallic strands can be shaped similar to the pattern formed by cutting the planar sheet.
As will be appreciated by one skilled in the art,method 1100 can include any of the various features of the disclosed technology described herein and can be varied depending on the particular configuration. Thus,method 1100 should not be construed as limited to the particular steps and order of steps explicitly described herein. It is noted that while the preference for the exemplary embodiments of the medical probe is for IRE or PFA, it is within the scope of the present invention to also use the medical probe separately only for RF ablation (unipolar mode with an external grounding electrode or bipolar mode) or in combination with IRE and RF ablations sequentially (certain electrodes in IRE mode and other electrodes in RF mode) or simultaneously (groups of electrodes in IRE mode and other electrodes in RF mode).
The disclosed technology described herein can be further understood according to the following clauses:

Clause 1: A medical probe, comprising: a tubular shaft having a proximal end and a distal end, the tubular shaft extending along a longitudinal axis of the medical probe; and an expandable basket assembly coupled to the distal end of the tubular shaft, the basket assembly comprising: a plurality of spines extending along the longitudinal axis and converging at a central spine intersection, each spine of the plurality of spines comprising: a plurality of electrodes, each electrode comprising an electrode body that defines a lumen therethrough such that the respective spine extends through the electrode body lumen, and an electrically insulative jacket disposed between a respective spine of the plurality of spines and a respective electrode of the plurality of electrodes, thereby electrically isolating the plurality of electrodes from the plurality of spines, in which a cross-sectional shape of each electrode body and electrically insulative jacket comprises a substantially circular shape.
Clause 2: The medical probe according to Clause 1, wherein the plurality of spines comprise a substantially rectangular cross-sectional shape; and wherein the electrically insulative jacket comprises a body defining an opening therethrough such that the respective spine extends through the electrically insulative jacket body, wherein the opening comprises a substantially rectangular cross-sectional shape.
Clause 3: The medical probe according to Clauses 1 and 2, wherein the electrically insulative jacket is disposed along at least a portion of the respective spine.
Clause 4: The medical probe according to Clauses 1 and 2, wherein the electrically insulative jacket is disposed along an entire length of the respective spine except for the central spine intersection.
Clause 5: The medical probe according to Clauses 1 and 2, wherein the electrically insulative jacket is disposed along an entire length of the respective spine except for the respective spine ends.
Clause 6: The medical probe according to any of Clauses 1-5, wherein a cross-sectional thickness of each electrode comprises a dimension substantially similar to the dimension of the spine, and wherein the cross-sectional thickness of each electrode is configured to allow each electrode to bow radially outward from the longitudinal axis when the expandable basket assembly is transitioned from a collapsed form to an expanded form.
Clause 7: The medical probe according to any of Clauses 1-6, wherein each of the electrically insulative jackets comprise a first lumen configured to receive the respective spine.
Clause 8: The medical probe according to any of Clauses 1-6, wherein each of the electrically insulative jackets comprise a first opening and a second opening, the first opening configured to receive a first wire and the second opening configured to receive the respective spine.
Clause 9: The medical probe according to Clause 1, wherein each spine of the plurality of spines further comprises a frame extrusion deposed between a respective spine and a respective electrically insulative jacket.
Clause 10: The medical probe according to Clause 9, wherein the frame extrusion is disposed along at least a portion of the respective spine.
Clause 11: The medical probe according toClauses 9 and 10, wherein the frame extrusion extends beyond an exit of the electrically insulative jacket proximate the central spine intersection.
Clause 12: The medical probe according toClauses 9 and 10, wherein the frame extrusion extends beyond an exit of the electrically insulative jacket proximate the respective spine end.
Clause 13: The medical probe according to Clauses 9-12, wherein the frame extrusion maintains a position of the electrically insulative jacket over the respective spine.
Clause 14: The medical probe according to any of Clauses 1-13, wherein the plurality of spines extend from the central spine intersection in an equiangular pattern such that respective angles between respectively adjacent spines are approximately equal.
Clause 15: The medical probe according to any of Clauses 1-13, wherein the expandable basket assembly comprises four to ten spines of the plurality of spines.
Clause 16: The medical probe according to Clause 1, wherein each respective spine of the plurality of spines comprises two electrodes.
Clause 17: The medical probe according to any of Clauses 1-16, further comprising a wire, wherein the electrode body lumen comprises a relief configured to receive the wire of the medical probe.
Clause 18: The medical probe according toClause 17, wherein the wire is electrically connected to the electrode.
Clause 19: The medical probe according to any ofClauses 17 and 18, wherein at least a portion of the wire comprises an electrically conductive core material comprising a first electrical conductivity, an electrically conductive cover material comprising a second electrical conductivity less than the first electrical conductivity, the electrically conductive cover material circumscribing the electrically conductive core material, and an insulative jacket circumscribing the electrically conductive cover material.
Clause 20: The medical probe according to any ofClauses 17 and 18, wherein at least a portion of the wire comprises a plurality of strands and an insulative jacket circumscribing the plurality of strands, and wherein each strand of the plurality of strands respectively comprises an electrically conductive core material comprising a first electrical conductivity and an electrically conductive cover material comprising a second electrical conductivity less than the first electrical conductivity, the electrically conductive cover material circumscribing the electrically conductive core material.
Clause 21: The medical probe according to any of Clauses 1-20, wherein the electrode body lumen is disposed symmetrically about a central axis of the electrode.
Clause 22: The medical probe according to any of Clauses 1-21, wherein the plurality of spines comprise a material selected from a group consisting of nitinol, cobalt chromium, stainless steel, titanium and combinations thereof.
Clause 23: The medical probe according to any of Clauses 1-21, wherein the plurality of spines comprise a polymer.
Clause 24: The medical probe according to any of Clauses 1-21, wherein the plurality of electrodes is configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).
Clause 25: The medical probe according to any of Clauses 1-24, wherein the plurality of spines is configured to form an approximately spherically-shaped basket assembly when in the expanded form.
Clause 26: The medical probe according to any of Clauses 1-24, wherein the plurality of spines is configured form an approximately oblate-spheroid basket assembly when in the expanded form.
Clause 27: The medical probe according to any of Clauses 1-26, further comprising spray ports configured to deliver an irrigation fluid to the plurality of electrodes.
Clause 28: A method of constructing a medical probe, the method comprising: aligning a spine of an expandable basket assembly with an electrode, the electrode comprising an electrode body defining a lumen therethrough such that the respective spine extends through the lumen of the electrode, the electrode body comprising a substantially circular cross-sectional shape; inserting the spine into the lumen of the electrode; and fitting an end of the spine to a tubular shaft sized to traverse vasculature such that the expandable basket assembly is movable from a tubular configuration to a bowed configuration.
Clause 29: The method according toClause 28, further comprising: positioning the spine of the expandable basket assembly through a first lumen of an electrically insulative jacket; positioning a wire through a second lumen of the electrically insulative jacket; positioning the electrode over the electrically insulative jacket; and electrically connecting the wire to the electrode through an aperture in the electrically insulative jacket providing passage between the second lumen and the electrode.
Clause 30: The method according toClause 28, wherein each respective spine of a plurality of spines comprises a first electrode and a second electrode, the method further comprising: positioning the spine of the expandable basket assembly through a first lumen of an electrically insulative jacket; aligning each respective spine of the plurality of spines with the first electrode and the second electrode; inserting each respective spine of the plurality of spines into a lumen of the first electrode and a lumen of the second electrode; and fitting ends of each respective spine of the plurality of spines to the tubular shaft sized to traverse vasculature.
Clause 31: The method according to any toClause 30, further comprising offsetting the electrodes between adjacent spines.
Clause 32: The method according to any of Clause 28-31, wherein a cross-sectional shape of the electrically insulative jacket comprises a substantially circular shape.
Clause 33: The method according to any of Clause 29-32, wherein the wire is insulated from the spine.
Clause 34: The method according to any of Clauses 29-33, wherein at least a portion of the wire comprises an electrically conductive core material comprising a first electrical conductivity, an electrically conductive cover material comprising a second electrical conductivity less than the first electrical conductivity, the electrically conductive cover material circumscribing the electrically conductive core material, and an insulative jacket circumscribing the electrically conductive cover material.
Clause 35: The method according to any of Clauses 29-33, wherein at least a portion of the wire comprises a plurality of strands and an insulative jacket circumscribing the plurality of the strands, and wherein each strand of the plurality of strands respectively comprises an electrically conductive core material comprising a first electrical conductivity and an electrically conductive cover material comprising a second electrical conductivity less than the first electrical conductivity, the electrically conductive cover material circumscribing the electrically conductive core material.
Clause 36: The method according to any of Clauses 28-35, wherein the plurality of spines comprise a material selected from a group consisting of nitinol, cobalt chromium, stainless steel, titanium.
Clause 37: The medical probe according to any of Clauses 28-35, wherein the plurality of spines comprise a polymer.
Clause 38: The method according to any of Clauses 28-37, further comprising configuring the electrode to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).
Clause 39: The method according to any of Clauses 28-38, further comprising configuring the plurality of spines to form an approximately spherically-shaped basket assembly.
Clause 40: The method according to any of Clauses 28-38, further comprising configuring the plurality of spines to form an approximately oblate-spheroid-shaped basket assembly.
Clause 41: The method according to any of Clauses 28-40, further comprising configuring spray ports to deliver an irrigation fluid to the electrode.
Clause 42: A spine basket member comprising: a plurality of spines extending radially from a longitudinal axis; a plurality of electrodes comprising an electrode body that defines a lumen therethrough such that each spine of the plurality of spines extends through the lumen; and an electrically insulative jacket disposed between a respective spine of the plurality of spines and a respective electrode of the plurality of electrodes, in which each electrode body and electrically insulative jacket comprises a substantially circular cross-section.
Clause 43: The spine basket member according toClause 42, further comprising: a cutout defining a first open area of empty space proximate the longitudinal axis, the first open area of empty space approximating a first virtual circle including a first diameter from the longitudinal axis, the cutout extending into each of the plurality of spines for a first length to define an open slot in each of the plurality of spines, each slot being contiguous to a circumference of a second virtual circle greater than the first virtual circle.
Clause 44: The spine basket member of Clause 43, wherein one of every other slots on the plurality of spines includes an aperture defining a third area smaller than the first open area of empty space.
Clause 45: The spine basket member ofClause 44, in which the second virtual circle defines a second area of approximately 36 times that of the third area.
Clause 46: The spine basket member of Clause 45, in which the second area comprises approximately 7 times the first open area of empty space.
Clause 47: The spine basket member of Clause 45, in which the third area is about ¼ of the open first area while a total negative surface area of the cutout includes approximately 1.6 times the first open area of empty space.
Clause 48: The spine basket member of Clause 45, in which the third area comprises a circle with a radius includes approximately 0.4 times that of a first radius of the first virtual circle and a radius of the second virtual circle includes approximately 2.8 times that of the first radius.
Clause 49: The spine basket member ofClause 48, in which the first open area of empty space comprises approximately 2 mm², the second area being approximately 15mm² and the third area includes approximately 0.4 mm² and a total area of all cutouts includes approximately 3.5 mm².
Clause 50: The spine basket member according toClause 42, further comprising: a tadpole shaped cutout on each of the plurality of spines, each cutout including a head portion contiguous to a circumference of a first virtual circle with a first radius disposed about the longitudinal axis, the head portion defining a negative area approximating a second virtual circle with a second radius, the head portion connected to a slotted tail portion extending for a first length along the spine and contiguous to an inside circumference of a third virtual circle including a third radius.
Clause 51: The spine basket member ofClause 50, in which the second radius includes approximately equal to that of a radius of the first virtual circle and the third radius includes approximately 8-15 times that of the radius of the first virtual circle.
Clause 52: The spine basket member according to Clause 51, in which the first length of the slotted tail portion includes approximately 6-10 times that of the length of the radius of the first virtual circle.
Clause 53: The spine basket member according toClause 50, further comprising a cutout disposed on the longitudinal axis to define a central negative area approximating a central circle including a central radius smaller than the first radius.
Clause 54: The spine basket member according toClause 50, in which the negative area of each of the tadpole cutouts includes approximately 0.2 mm² while the negative area of the central circle includes approximately 0.05mm² so that the total negative area defined by all of the cutouts includes approximately 1.4mm².
Clause 55: The spine basket member according toClause 50, in which central void radius comprises approximately 0.13mm, the second radius comprises approximately 0.2mm, and the first radius comprises approximately 0.23mm.
Clause 56: The spine basket member according toClause 50, in which the cutout defines a comet-shaped cutout with head portion with a slotted tapered tail extending to a proximal portion of each spine.
Clause 57: The spine basket member according toClause 56, further comprising a circular hole located on the longitudinal axis of the spines with a central radius from the longitudinal axis.
Clause 58: The spine basket member according to Clause 57, wherein first radius includes approximately 90% of the central radius, the second virtual circle includes a second radius of approximately 2.5 times that of central radius while the third virtual circle includes a radius of approximately 10 times that of the central radius.
Clause 59: The spine basket member according toClause 58, wherein each spine includes a first spine width that tapers towards the longitudinal axis to a smaller second spine width and further sub-dividing into two narrower spine arms running along the comet-shaped cutout by a portion comprising the comet-shaped cutout, each narrow spine arm including a third spine width.

The embodiments described above are cited by way of example, and the present invention is not limited by what has been particularly shown and described hereinabove. Rather, the scope of the invention includes both combinations and sub combinations of the various features described and illustrated hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art.

Claims

A medical probe, comprising:
a tubular shaft having a proximal end and a distal end, the tubular shaft extending along a longitudinal axis of the medical probe; and
an expandable basket assembly coupled to the distal end of the tubular shaft, the basket assembly comprising:
a plurality of spines extending along the longitudinal axis and converging at a central spine intersection, each spine of the plurality of spines comprising:
a plurality of electrodes, each electrode comprising an electrode body that defines a lumen therethrough such that the respective spine extends through the lumen, and
an electrically insulative jacket disposed between a respective spine of the plurality of spines and a respective electrode of the plurality of electrodes, thereby electrically isolating the plurality of electrodes from the plurality of spines,
in which a cross-sectional shape of each electrode body and electrically insulative jacket comprises a substantially circular shape.
The medical probe according to claim 1, wherein the plurality of spines comprise a substantially rectangular cross-sectional shape; and
wherein the electrically insulative jacket comprises a body defining an opening therethrough such that the respective spine extends through the electrically insulative jacket body, wherein the opening comprises a substantially rectangular cross-sectional shape.
The medical probe according to claim 1 or claim 2, wherein the electrically insulative jacket is disposed along an entire length of the respective spine except for the central spine intersection, or except for the respective spine ends.
A spine basket member comprising:
a plurality of spines extending radially from a longitudinal axis;
a plurality of electrodes comprising an electrode body that defines a lumen therethrough such that each spine of the plurality of spines extends through the lumen; and
an electrically insulative jacket disposed between a respective spine of the plurality of spines and a respective electrode of the plurality of electrodes,
in which each electrode body and electrically insulative jacket comprises a substantially circular cross-section.
The medical probe according to claim 1 or claim 2 or the spine basket member according to claim 4, wherein the electrically insulative jacket is disposed along at least a portion of the respective spine.
The medical probe according to claim 1 or the spine basket member according to claim 4, wherein each spine of the plurality of spines further comprises a frame extrusion deposed between a respective spine and a respective electrically insulative jacket.
The medical probe according to claim 6, wherein the frame extrusion is disposed along at least a portion of the respective spine.
The medical probe according to claim 6 or claim 7, wherein the frame extrusion maintains a position of the electrically insulative jacket over the respective spine.
The spine basket member according to claim 4, wherein each respective spine of the plurality of spines comprises two electrodes.
The spine basket member according to claim 4, further comprising:
a cutout defining a first open area of empty space proximate the longitudinal axis, the first open area of empty space approximating a first virtual circle including a first diameter from the longitudinal axis, the cutout extending into each of the plurality of spines for a first length to define an open slot in each of the plurality of spines, each slot being contiguous to a circumference of a second virtual circle greater than the first virtual circle.
The spine basket member of claim 10, wherein one of every other slots on the plurality of spines includes an aperture defining a third area smaller than the first open area of empty space.
The spine basket member according to claim 4, further comprising:
a tadpole shaped cutout on each of the plurality of spines, each cutout including a head portion contiguous to a circumference of a first virtual circle with a first radius disposed about the longitudinal axis, the head portion defining a negative area approximating a second virtual circle with a second radius, the head portion connected to a slotted tail portion extending for a first length along the spine and contiguous to an inside circumference of a third virtual circle including a third radius, optionally in which the cutout defines a comet-shaped cutout with head portion with a slotted tapered tail extending to a proximal portion of each spine, further optionally comprising a circular hole located on the longitudinal axis of the spines with a central radius from the longitudinal axis.
A method of constructing a medical probe, the method comprising:
aligning a spine of an expandable basket assembly with an electrode, the electrode comprising an electrode body defining a lumen therethrough such that the respective spine extends through the lumen of the electrode, the electrode body comprising a substantially circular cross-sectional shape;
inserting the spine into the lumen of the electrode; and
fitting an end of the spine to a tubular shaft sized to traverse vasculature such that the expandable basket assembly is movable from a tubular configuration to a bowed configuration.
The method according to claim 13, wherein each respective spine of a plurality of spines comprises a first electrode and a second electrode, the method further comprising:
positioning the spine of the expandable basket assembly through a first lumen of an electrically insulative jacket;
aligning each respective spine of the plurality of spines with the first electrode and the second electrode;
inserting each respective spine of the plurality of spines into a lumen of the first electrode and a lumen of the second electrode; and
fitting ends of each respective spine of the plurality of spines to the tubular shaft sized to traverse vasculature.
The method according to any to claim 14, further comprising offsetting the electrodes between adjacent spines.